Actively Recruiting
A New Study Evaluating the Activity of Modular CAR T for mYeloma
Led by University College, London · Updated on 2025-11-20
27
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.
CONDITIONS
Official Title
A New Study Evaluating the Activity of Modular CAR T for mYeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma
- Secretory disease with specific protein or light chain levels and abnormal K:L ratio
- Have received at least three prior lines of therapy including proteasome inhibitor, IMiD, and anti-CD38 antibody
- Refractory to last line of therapy with progression within specified timeframes
- Previously received or unsuitable for autologous stem cell transplant (ASCT)
- ECOG performance status of 0 or 1
- Adequate kidney function, neutrophil count, platelet count, hemoglobin, and lymphocyte count
- Weight over 30 kilograms
- Agreement to pregnancy testing and use of contraception if applicable
- Written informed consent provided
You will not qualify if you...
- Previous diagnosis of systemic light chain amyloidosis
- Prior treatment with gene therapy or cell therapy products
- Allogeneic stem cell transplant within 12 months or moderate/severe chronic GVHD requiring immunosuppression
- Oxygen saturation 90% or less on air
- Uncontrolled or recent significant heart disease or events
- Left ventricular ejection fraction below 50%
- Prolonged QT interval above 470 ms or uncontrolled arrhythmia (except controlled atrial fibrillation)
- History of deep vein thrombosis or pulmonary embolism requiring ongoing anticoagulation
- Chronic renal impairment requiring dialysis
- Significant liver disease or end-stage liver disease
- Major surgery within the last 3 months (except certain vertebral procedures)
- Active gastrointestinal bleeding
- Active bacterial or viral infection requiring treatment
- Known active central nervous system involvement or recent major neurological conditions
- Use of corticosteroids above specified doses that cannot be stopped
- Active autoimmune disease needing immunosuppression
- Past or current other cancers
- Recent radiotherapy or anti-myeloma therapy within 7 days before treatment
- Inability to tolerate leukapheresis
- Life expectancy less than 3 months
- Pregnancy or breastfeeding
- Allergy to albumin or DMSO
- Active infection or fever before scheduled CAR-T cell infusion
- Need for supplementary oxygen at the time of scheduled CAR-T cell infusion
- Clinical worsening of liver or kidney function beyond entry criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University College London Hospital
London, County (Optional), United Kingdom
Actively Recruiting
Research Team
M
MCARTY Trial Coordinator
CONTACT
L
Lydia Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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